NCT06606769

Brief Summary

Bone tissue is crucial for overall health and quality of life, but it undergoes constant internal remodeling, leading to osteoporosis, a widespread bone disease. Regular physical activity can improve bone mineral density (BMD) and prevent osteoporosis. Studies have shown that premenopausal women with regular physical activity have greater BMD. Diagnosing bone resorption is essential, and dual-energy X-ray absorptiometry tests (DXA) and circulating microRNAs (miRNAs) may offer more prognostic potential than conventional markers. The gut microbiome may also regulate bone metabolism, with metabolites like trimethylamine N-oxide (TMAO) playing a role. A project aims to promote systematic physical activity to improve BMD and well-being, support societal mobilization, and conduct preventive examinations for osteoporosis risk. Implementing systematic prevention is important not only for health but also for reducing social and financial costs associated with osteoporosis and associated fractures.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
13mo left

Started Sep 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress61%
Sep 2024Jun 2027

Study Start

First participant enrolled

September 13, 2024

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

September 18, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 23, 2024

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2027

Last Updated

October 10, 2024

Status Verified

September 1, 2024

Enrollment Period

2.3 years

First QC Date

September 18, 2024

Last Update Submit

October 8, 2024

Conditions

Keywords

physical activitybone mineral density

Outcome Measures

Primary Outcomes (1)

  • bone mineral density

    BMD using dual-energy X-ray absorptiometry (DXA)

    before and after 12 months of intervention

Secondary Outcomes (2)

  • blood markers

    before and after 12 months of intervention

  • physical fitness tests

    before and after 12 months of intervention

Study Arms (1)

exercise

EXPERIMENTAL

supervised exercise training; twice a week for 12 months

Other: Exercise

Interventions

supervised exercise training; twice a week for 12 months

exercise

Eligibility Criteria

Age50 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • women

You may not qualify if:

  • diagnosed osteoporosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Poznan University of Physical Education

Poznan, 61-871, Poland

RECRUITING

MeSH Terms

Conditions

OsteoporosisBone Diseases, MetabolicMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Bone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Robert A Olek, professor

    Poznan University of Physical Education

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Maja Mackowiak

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 18, 2024

First Posted

September 23, 2024

Study Start

September 13, 2024

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

June 30, 2027

Last Updated

October 10, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

we will consider sharing individual participant data in the future

Locations